The current disclosure relates to prosthetic heart valves, and more particularly to apparatus for use in holding such valves prior to and during implantation of the valve in a patient.
Prosthetic heart valves are used for replacing diseased and/or deficient valves in a patient's heart. For example, a patient's mitral and/or aortic valves may need to be replaced by such prostheses. One illustrative type of prosthetic heart valve includes animal tissue that has been treated to make it suitable for long-term use in a patient's body. The valve implantation may be done in an “open heart” surgical procedure or a minimally invasive procedure.
During the implantation procedure, it may be desirable to temporarily modify the shape of the prosthetic tissue valve in certain respects in order to facilitate placement of the valve in the patient with good visualization and with good access for suturing the valve to the native tissue of the patient. For example, this temporary shape modification may include deflecting free end portions of the commissural posts of the prosthetic tissue valve radially inwardly. This shape modification is preferably done just prior to the implantation procedure to avoid any part of the valve taking an undesirable “set” during prolonged deformation, and may be especially useful in minimally invasive procedures in which there is limited space for a surgeon to work. Typical valve holders are disclosed, for example, in U.S. Pat. Nos. 4,865,600, 6,214,043, 6,409,758, 7,568,073, 7,503,929 and RE42,395.
The above aspects of prosthetic tissue valve handling may be aided by associating the valve with a so-called holder. This association may include, for example, a suture connection between the valve and the holder. The holder can be used to hold the valve in its storage liquid. When it is desired to use, or implant, the valve, a handle can be removably attached to the holder to remove the holder and valve from the storage liquid and to hold those components during the rinsing of the valve. Attachment of the handle to the holder (or subsequent manipulation of the handle relative to the holder) may also be used to cause the above-described temporary deformation of the valve. The handle may also be used to place the holder and valve in the patient. The handle may be removed from the holder during suturing of the valve into the patient. The handle may then be re-attached to the holder so that when the sutures connecting the valve to the holder are cut, the handle can be used to remove the holder from the patient, leaving only the valve in the patient.
Holders that are large, bulky, or that increase the effective diameter of the valve being held, may be undesirable. For example, if a surgeon is implanting a valve connected to a holder into a patient, a bulky holder may limit the ability for the surgeon to visualize the surgical working area. A surgeon may thus be provoked into removing the valve from a bulky holder during implantation. Without the protection of the holder, the valve may be more likely to be damaged during implantation.
From the foregoing it will be seen that a less bulky prosthetic valve holder that protects the valve and has the ability to decrease the valve profile is desired.